Non-Pharmacological Alternatives to Proton Pump Inhibitors: Comparative Clinical Effectiveness and Guidelines - Cadth

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CADTH RAPID RESPONSE REPORT: SUMMARY OF ABSTRACTS

Non-Pharmacological
Alternatives to Proton Pump
Inhibitors: Comparative
Clinical Effectiveness and
Guidelines

 Service Line:       Rapid Response Service
 Version:            1.0
 Publication Date:   May 11, 2018
 Report Length:      8 Pages
Authors: Michelle Clark, Melissa Severn

    Cite As: Non-Pharmacological Alternatives to Proton Pump Inhibitors: Comparative Clinical Effectiveness and Guidelines . Ottawa: CADTH;2018 May .
    (CADTH rapid response report: summary of abstracts).

    Acknowledgments:

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SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors                                                                                            2
Research Questions
                                             1. What is the comparative clinical effectiveness of non-pharmacological or alternative
                                                interventions compared to proton pump inhibitors for patients with disorders of
                                                excessive acid secretion?

                                             2. What are the evidence-based guidelines for non-pharmacological or alternative
                                                interventions for patient with excessive acid secretion?

                                              Key Findings
                                             One non-randomized study and three evidence-based guidelines were identified regarding
                                             the comparative clinical effectiveness of non-pharmacological or alternative interventions
                                             compared to proton pump inhibitors for patients with disorders of excessive acid secretion.

                                              Methods
                                             A limited literature search was conducted on key resources including PubMed, The
                                             Cochrane Library, University of York Centre for Reviews and Dissemination (CRD)
                                             databases, Canadian and major international health technology agencies, a s well as a
                                             focused Internet search. No filters were applied to limit the retrieval by study type. The
                                             search was also limited to English language documents published between Jan 1, 2013
                                             and Apr 30, 2018. Internet links were provided, where available.

                                              Selection Criteria
                                             One reviewer screened citations and selected studies based on the inclusion criteria
                                             presented in Table 1.

Table 1: Selection Criteria
Population                 Patients with disorders of excessive acid secretion (e.g., acid reflux, gastroesophageal reflux disease)

Interventions              Non-drug alternatives to proton pump inhibitors (PPIs) (i.e., lifestyle changes – e.g., avoidance of acidic
                           foods, avoiding lying down after eating, avoiding tight fitting clothes, stopping smoking, elevation of the
                           head and neck, eating smaller meals and chewing more thoroughly, losing weight)

Comparators                Q1: PPIs
                           Q2: No comparator

Outcomes                   Q1: Clinical effectiveness (e.g., change in symptoms), safety (e.g., adverse events)
                           Q2: Evidence based guidelines

Study Designs              Health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, non-
                           randomized studies, evidence-based guidelines

SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors                                                          3
Results
                                             Rapid Response reports are organized so that the higher quality evidence is presented first.
                                             Therefore, health technology assessment reports, systematic reviews, and meta -analyses
                                             are presented first. These are followed by randomized controlled trials, non -randomized
                                             studies, and evidence-based guidelines.

                                             One non-randomized study and three evidence-based guidelines were identified regarding
                                             the comparative clinical effectiveness of non-pharmacological or alternative interventions
                                             compared to proton pump inhibitors for patients with disorders of excessive acid secretion
                                             and guidelines for management. No relevant health technology assessments, systematic
                                             reviews, or randomized controlled trials were identified.

                                             Additional references of potential interest are provided in the appendix.

                                              Overall Summary of Findings
                                             One non-randomized study1 compared the consumption of alkaline water and a mostly
                                             plant-based Mediterranean diet with standard reflux precautions with the use of proton
                                             pump inhibitors (PPIs) and standard reflux precautions for the management of
                                             laryngopharyngeal reflux. A greater percentage of patients in the diet group achieved a
                                             clinically meaningful reduction in the Reflux Symptoms Index, but the difference was not
                                             statistically significant. Despite the lack of a significant difference in outcome s between
                                             groups, the authors suggested that the dietary approach should be considered as an option
                                             for the treatment of reflux because of the lower cost and lack of adverse events when
                                             compared with PPIs.1

                                             A guideline from the University of Michigan 2 recommends that patients be prescribed
                                             lifestyle interventions for the treatment of gastroesophageal reflux disease (GERD)
                                             including: smoking cessation, avoiding specific foods, avoiding large meals, and avoiding
                                             certain medications, but specifies that only the recommendations for weight los s and
                                             avoiding lying flat after meals are based on evidence-based data.2 A guideline for the
                                             management of GERD and dyspepsia in adults from the National Institute for Health and
                                             Care Excellence 3 recommends advice related to healthy eating, weight loss, an d smoking
                                             cessation should be provided to all patients seeking treatment for GERD. The American
                                             College of Gastroenterology4 recommends a number of lifestyle interventions for the
                                             management of GERD including weight loss for patients who are overweight, el evation of
                                             the head of the bed, and avoiding meals two to three hours before bedtime.

                                              References Summarized
                                              Health Technology Assessments
                                             No literature identified.

                                              Systematic Reviews and Meta-analyses
                                             No literature identified.

                                              Randomized Controlled Trials
                                             No literature identified.

SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors                                                         4
Non-Randomized Studies

                                             1. Zalvan CH, Hu S, Greenberg B, Geliebter J. A Comparison of Alkaline Water and
                                                Mediterranean Diet vs Proton Pump Inhibition for Treatment of Laryngopharyngeal
                                                Reflux. JAMA Otolaryngol Head Neck Surg. 2017 Oct 1;143(10):1023-9. Available
                                                from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5710251
                                                PubMed: PM28880991

                                              Guidelines and Recommendations

                                             2. Gastroesophageal reflux disease (GERD) [Internet]. Ann Arbor (MI): Regents of the
                                                University of Michigan; 2013 Sep. [cited 2018 May 11; content reviewd 2018 Mar].
                                                Available from: https://www.med.umich.edu/1info/FHP/practiceguides/gerd/gerd.12.pdf

                                             3. Gastro-oesophageal reflux disease and dyspepsia in adults: investigation and
                                                management [Internet]. London: The National Institute for Health and Care Excellence;
                                                2014 Nov. [cited 2018 May 11]. (Clinical guideline [CG184]). Available from:
                                                https://www.nice.org.uk/guidance/cg184
                                                See: 1.2.1, page 10

                                             4. Katz PO, Gerson LB, Vela MF. Diagnosis and management of gastroesophageal reflux
                                                disease. Am J Gastroenterol [Internet]. 2013 [cited 2018 May 11];108:308 -28. Available
                                                from: https://gi.org/guideline/diagnosis-and-managemen-of-gastroesophageal-reflux-
                                                disease/

SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors                                                        5
Appendix — Further Information
                                              Previous CADTH Reports

                                             5. Proton Pump Inhibitors for Gastrointestinal Conditions: A Review of Clinical
                                                Effectiveness and Cost-Effectiveness [Internet]. Ottawa: CADTH; 2015 Jun 19. [cited
                                                2018 May 11]. (Rapid response summary with critical appraisal). Available from:
                                                https://www.cadth.ca/proton-pump-inhibitors-gastrointestinal-conditions-review-clinical-
                                                effectiveness-and-cost

                                             6. Proton Pump Inhibitors Cessation Programs: A Review of Clinical Effectiveness, Cost-
                                                effectiveness and Guidelines [Internet]. Ottawa: CADTH; 2014 Oct 2. [cited 2018 May
                                                11]. (Rapid response summary with critical appraisal). Available from:
                                                https://www.cadth.ca/proton-pump-inhibitors-cessation-programs-review-clinical-
                                                effectiveness-cost-effectiveness-and

                                              Systematic Reviews and Meta-Analyses – No Comparison to PPIs
                                             7. Casale M, Sabatino L, Moffa A, Capuano F, Luccarelli V, Vitali M, et al. Breathing
                                                training on lower esophageal sphincter as a complementary treatment of
                                                gastroesophageal reflux disease (GERD): a systematic review. Eur Rev Med Pharmacol
                                                Sci. 2016 Nov;20(21):4547-52.
                                                PubMed: PM27874942

                                             8. Kang JH, Kang JY. Lifestyle measures in the management of gastro -oesophageal reflux
                                                disease: clinical and pathophysiological considerations. Ther Adv Chronic Dis. 2015
                                                Mar;6(2):51-64. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4331235
                                                PubMed: 25729556

                                              Non-Randomized Studies
                                              Lifestyle Interventions in Combination with Pharmaceutical Interventions
                                             9. Ong AM, Chua LT, Khor CJ, Asokkumar R, Namasivayam O, Wang YT. Diaphragmatic
                                                Breathing Reduces Belching and Proton Pump Inhibitor Refractory Gastroesophageal
                                                Reflux Symptoms. Clin Gastroenterol Hepatol. 2018 Mar;16(3):407-16.
                                                PubMed: PM29104130

                                             10. Allampati S, Lopez R, Thota PN, Ray M, Birgisson S, Gabbard SL. Use of a positional
                                                 therapy device significantly improves nocturnal gastroesophageal reflux symptoms. Dis
                                                 Esophagus. 2017 Feb 1;30(3):1-7.
                                                 PubMed: PM27629558

                                             11. Haruma K, Kinoshita Y, Sakamoto S, Sanada K, Hiroi S, Miwa H. Lifestyle factors and
                                                 efficacy of lifestyle interventions in gastroesophageal reflux disease patients with
                                                 functional dyspepsia: primary care perspectives from the LEGEND study. Intern Med.
                                                 2015;54(7):695-701.
                                                 PubMed: PM25832928

SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors                                                        6
Not Compared with PPIs
                                             12. Randhawa MA, Mahfouz SA, Selim NA, Yar T, Gillessen A. An old dietary regimen as a
                                                 new lifestyle change for Gastro esophageal reflux disease: A pilot study. Pak J Pharm
                                                 Sci. 2015 Sep;28(5):1583-6.
                                                 PubMed: PM26408867

                                              Clinical Practice Guidelines – Methodology Not Specified
                                            13. Dagli U, Kalkan IH. The role of lifestyle changes in gastroesophageal reflux diseases
                                                treatment. Turk J Gastroenterol [Internet]. 2017 [cited 2018 May 11];28 (suppl 1):S33-
                                                S37. Available from: http://www.turkjgastroenterol.org/sayilar/303/buyuk/S33-S37.pdf

                                            14. Richardson B. the role of nutrition in preventing and managing GERD. Nutrition &
                                                Foodservice EDGE [Internet]. 2017 [cited 2018 May 11];July - August. Available from:
                                                https://www.anfponline.org/docs/default-source/legacy-docs/docs/ce-
                                                articles/nc072017.pdf

                                            15. Gastroesophageal reflux disease (GERD) [Internet]. Portland (OR): The Portland Clinic;
                                                2013. [cited 2018 May 11]. Available from: http://www.theportlandclinic.com/wp-
                                                content/uploads/2017/01/10560-Gastroesophageal-Reflux-Disease.pdf

                                             Review Articles
                                             16. Chuang TW, Chen SC, Chen KT. Current status of gastroesophageal reflux disease :
                                                 diagnosis and treatment. Acta Gastroenterol Belg. 2017 Jul;80(3):396-404.
                                                 PubMed: PM29560670

                                             17. Patti MG. An Evidence-Based Approach to the Treatment of Gastroesophageal Reflux
                                                 Disease. JAMA Surg. 2016 Jan;151(1):73-8.
                                                 PubMed: PM26629969

                                             18. Treating heartburn and gastro-esophageal relflux (GERD) [Internet]. Toronto: Choosing
                                                 Wisely Canada; 2014 Oct 29. [cited 2018 May 11]. Available from:
                                                 https://choosingwiselycanada.org/wp-content/uploads/2017/05/GERD-EN.pdf

                                              Additional References
                                             19. Kroch DA, Madanick RD. Medical Treatment of Gastroesophageal Reflux Disease.
                                                 World J Surg. 2017 Jul;41(7):1678-84.
                                                 PubMed: PM28321555

                                             20. Keung C, Hebbard G. The management of gastro-oesophageal reflux disease. Aust
                                                 Prescr. 2016 Feb;39(1):6-10. Available from:
                                                 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4816873
                                                 PubMed: PM27041798

                                             21. Badillo R, Francis D. Diagnosis and treatment of gastroesophageal reflux disease.
                                                 World J Gastrointest Pharmacol Ther. 2014 Aug 6;5(3):105-12. Available from:
                                                 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4133436
                                                 PubMed: PM25133039

SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors                                                         7
22. Diet and gastroesophageal reflux disease (GERD) [Internet]. Downers Grove (IL):
                                                 American Society for Gastrointestinal Endoscopy; 2014. [cited 2018 May 11]. Available
                                                 from: https://www.asge.org/docs/default-source/about-asge/newsroom/doc-
                                                 gerd_infographic_final.pdf

SUMMARY OF ABSTRACTS Non-Pharmacological Alternativ es to Proton Pump Inhibitors                                                         8
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